Last Updated: May 31, 2026

Details for Patent: 3,624,205


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Summary for Patent: 3,624,205
Title:Treatment of hyperuricemia in humans
Abstract:The method of treatment and prophylaxis for hyperuricemia, which comprises administering to a human patient a therapeutically effective amount of a compound selected from the class consisting of 4-hydroxy-1-H-pyrazolo(3,4-d)pyrimidine and 4,6-dihydroxy-1-Hpyrazolo(3,4-d)pyrimidine.
Inventor(s):George H Hitchings, Elvira A Falco
Assignee: SmithKline Beecham Corp
Application Number:US633364A
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

United States Patent 3,624,205: Claim Scope and U.S. Patent Landscape for Pyrazolo(3,4-d)pyrimidine Hyperuricemia Methods

What do the asserted claims cover in the U.S.?

U.S. Drug Patent 3,624,205 is framed as a method of treatment and prophylaxis for hyperuricemia using specific pyrazolo(3,4-d)pyrimidine compounds. The claim set provided is heavily indication- and dosage-bounded, with coverage focused on administration to a human patient.

Claim-by-claim scope (based on the text supplied)

Claim Claim category Treated condition / purpose Active compound(s) recited Dosage limitation Practical reading of scope
2 Method, dependent on claim 1 Not separately stated (tied to claim 1’s method) 4-hydroxy-1-H-pyrazolo(3,4-d)pyrimidine 2 to 30 mg/kg Covers administration of the named compound at a human dose in the claimed range. Outside this range, claim 2 does not apply (unless claim 1 or other independent claims cover).
3 Method Hyperuricemia (treatment and prophylaxis) 4,6-dihydroxy-1-H-pyrazolo(3,4-d)pyrimidine None stated Covers using that specific compound for both treating and preventing hyperuricemia in humans, without an explicit mg/kg range.
4 Method, dependent on claim 3 Hyperuricemia (treatment and prophylaxis) 4,6-dihydroxy-1-H-pyrazolo(3,4-d)pyrimidine 2 to 30 mg/kg Narrows claim 3 by adding the same 2 to 30 mg/kg human dosage window.
5 Method Hyperuricemia (treatment and prophylaxis) Selected from the class: (i) 4-hydroxy-1-H-pyrazolo(3,4-d)pyrimidine and (ii) 4,6-dihydroxy-1-H-pyrazolo(3,4-d)pyrimidine None stated Broadens coverage across the two listed actives for hyperuricemia treatment/prophylaxis, without dosage limitation.

Core claim structure: how enforcement is likely to work

  1. Human patient requirement: Each method claim recites administration to “a human patient,” which targets human use and excludes non-human administration for infringement purposes.
  2. Indication tie-in: “for hyperuricemia” anchors the method to a disease state, narrowing the actionable conduct to use associated with hyperuricemia treatment or prophylaxis.
  3. Compound specificity: The actives are named, not defined by functional markers. Scope turns on whether the administered compound matches the recited structures.
  4. Dosage-bounded variants: Claims 2 and 4 add a 2 to 30 mg/kg dosage limitation. Claims 3 and 5 are not dosage-limited on the provided text, which matters for both infringement and design-around.

What is the effective claim “coverage perimeter” for competitors?

Covered drug substances (from the supplied claims)

The independent breadth in the provided dependent set comes from the “class consisting of” language in claim 5. That means only these two compounds are within that class:

  • 4-hydroxy-1-H-pyrazolo(3,4-d)pyrimidine
  • 4,6-dihydroxy-1-H-pyrazolo(3,4-d)pyrimidine

Covered disease use

The method claims are limited to:

  • Method of treatment and prophylaxis for hyperuricemia

So, for infringement analysis, the relevant question is whether the administered compound is used to treat or prevent hyperuricemia in humans, not whether it merely affects uric acid chemistry.

Dosage perimeter (where explicitly present)

Only two claims restrict dose:

  • 2 to 30 mg/kg body weight (claims 2 and 4)

Implications:

  • If a competitor uses only the recited compounds but administers outside 2 to 30 mg/kg, claims 2 and 4 are avoided, but claims 3 and 5 may remain available if dosage is not otherwise required in the governing independent claim.
  • If a competitor uses the two recited compounds within 2 to 30 mg/kg, it may be exposed under both the compound-specific and class-based dosage-limited claims.

How broad are the claims across chemical space?

Narrow by chemical definition; medium by indication and administration mode

  • Chemical scope is narrow: two explicitly named small molecules.
  • Indication scope is not tied to a specific mechanism-of-action (based on the provided claim text); it is tied to the clinical endpoint: hyperuricemia treatment/prophylaxis.
  • Administration mode is generic “administering,” not limited to route (oral, parenteral), dosage form (tablet, capsule), or formulation. That usually enlarges real-world coverage unless the full patent file or other claims constrain route.

“Class consisting of” vs “selected from”

Claim 5 uses “selected from the class consisting of,” which is a closed selection. That matters:

  • Adding a third pyrazolo(3,4-d)pyrimidine compound would fall outside claim 5 unless it is one of the two listed structures.
  • Reformulating those exact named compounds does not change whether the compound meets the claim; it changes whether the method is proven.

Patent landscape implications in the U.S. (what can be concluded from the claim text provided)

The supplied text is insufficient to map the entire U.S. patent family, priority chain, related continuations, or later-subsequent patents in the same chemical series. What can be concluded from the claim structure alone is how this patent is likely to sit in a landscape:

1) This is a use-method patent, not a composition-of-matter claim (based on the claims supplied)

The provided claims are method claims directed to administration for hyperuricemia. If there is no composition claim in the omitted claim set, competitors can potentially develop:

  • different dosage forms,
  • different use regimens not covered by the method claims,
  • other actives not within the recited structures, without automatically triggering infringement purely by possessing or selling the compound (depending on whether other claims exist in the full patent).

2) The dosage-limited claims create a narrower “operating window”

Claims 2 and 4 constrain only two variants. That tends to create a landscape where:

  • an infringement risk peak exists when dosing falls within 2 to 30 mg/kg, and
  • a partial design-around exists by altering dose outside that window (while still potentially facing claims without dosage bounds, like claims 3 and 5, depending on the independent claim’s structure).

3) The hyperuricemia use anchor limits cross-indication arguments

A competitor using the same compound for a different indication could argue the method claim’s disease tie-in is not satisfied. If the competitor markets or prescribes for gout, renal handling, or another urate-related endpoint, infringement hinges on whether that use is legally and factually linked to “hyperuricemia” as claimed.

Practical infringement and freedom-to-operate targets (for the two recited actives)

When does the risk stay high?

Risk stays high if a product:

  • contains one of the two named compounds, and
  • is prescribed or used for treatment and/or prophylaxis of hyperuricemia, and
  • (for claims 2/4) dosing falls in 2 to 30 mg/kg.

Where are the clearest claim holes, based on the provided text?

  • Dose carve-out: avoid 2 to 30 mg/kg to reduce exposure to claims 2 and 4.
  • Chemical carve-out: use a different compound not equal to either of the two named structures to avoid claim 5’s closed class.
  • Indication carve-out: use for an endpoint not framed as “hyperuricemia” in the infringement analysis.

Key Takeaways

  • The patent’s provided method claims cover hyperuricemia treatment and prophylaxis in humans using two specific pyrazolo(3,4-d)pyrimidine compounds: 4-hydroxy-1-H-pyrazolo(3,4-d)pyrimidine and 4,6-dihydroxy-1-H-pyrazolo(3,4-d)pyrimidine.
  • Claim 5 is the broadest in the provided set because it covers the two-compound closed class for hyperuricemia treatment/prophylaxis without a dosage limit.
  • Claims 2 and 4 add a clear dosing constraint of 2 to 30 mg/kg, narrowing those claim versions to that dosage window.
  • The chemical scope is tightly defined; the practical exposure turns on which exact compound is administered, whether the use is for hyperuricemia, and whether dosing falls within 2 to 30 mg/kg.

FAQs

1) Do the claims cover treatment only, or both treatment and prevention?

They cover both: the claims explicitly say “method of treatment and prophylaxis for hyperuricemia.”

2) Are both compounds treated the same way in the claims?

Not exactly. The two-compound selection appears in claim 5 without dosage limits, while dosage limits attach separately in claims 2 (for the 4-hydroxy compound) and 4 (for the 4,6-dihydroxy compound).

3) Does claim 5 require the 2 to 30 mg/kg dose?

No. On the provided text, claim 5 does not state a dosage range. The dosage range appears only in claims 2 and 4.

4) Is the “class consisting of” language limiting?

Yes. “Selected from the class consisting of” is a closed set. Only the two named compounds are inside that class.

5) If a competitor uses one of the named compounds outside 2 to 30 mg/kg, are they protected?

Claims 2 and 4 would not fit the dosage-bounded versions, but exposure could remain under claims without dosage limits (as reflected by the absence of a dose range in claims 3 and 5 on the supplied text).

References

  1. United States Patent No. 3,624,205 (claims as provided in the prompt).

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Drugs Protected by US Patent 3,624,205

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 3,624,205

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom23,055/55Aug 10, 1955
United Kingdom19,863/62May 23, 1962
United Kingdom34,519/62Aug 23, 1962

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